EP0904099B1 - Pharmaceutical formulation containing human growth hormone, histidine and a non-ionic detergent - Google Patents
Pharmaceutical formulation containing human growth hormone, histidine and a non-ionic detergent Download PDFInfo
- Publication number
- EP0904099B1 EP0904099B1 EP97918073A EP97918073A EP0904099B1 EP 0904099 B1 EP0904099 B1 EP 0904099B1 EP 97918073 A EP97918073 A EP 97918073A EP 97918073 A EP97918073 A EP 97918073A EP 0904099 B1 EP0904099 B1 EP 0904099B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- growth hormone
- hgh
- formulation
- amount
- histidine
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
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Classifications
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- A—HUMAN NECESSITIES
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- A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
Definitions
- the kinetics of degradation depend on temperature, pH and various additives or adjuvants in the hGH formulation.
- the pH of the formulation may be adjusted by adding an acid which has no adverse effect on the growth hormone, preferably a physiologically acceptable acid, e.g. a mineral acid such as hydrochloric acid, sulphuric acid or nitric acid, or an organic acid such as acetic acid or citric acid.
- a physiologically acceptable acid e.g. a mineral acid such as hydrochloric acid, sulphuric acid or nitric acid, or an organic acid such as acetic acid or citric acid.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- Endocrinology (AREA)
- Physical Education & Sports Medicine (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Rheumatology (AREA)
- Immunology (AREA)
- Diabetes (AREA)
- Dermatology (AREA)
- Reproductive Health (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Molecular Biology (AREA)
- Neurology (AREA)
- Biochemistry (AREA)
- Gynecology & Obstetrics (AREA)
- Pregnancy & Childbirth (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DK97918073T DK0904099T3 (da) | 1996-04-24 | 1997-04-24 | Farmaceutisk formulering, der indeholder humant væksthormon, histidin og et ikke-ionisk detergent |
| EP05110701A EP1629832A1 (en) | 1996-04-24 | 1997-04-24 | A pharmaceutical formulation comprising human growth hormone, an amino acid and a non-ionic detergent |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DK49096 | 1996-04-24 | ||
| DK49096 | 1996-04-24 | ||
| PCT/DK1997/000184 WO1997039768A1 (en) | 1996-04-24 | 1997-04-24 | A pharmaceutical formulation containing growth hormone, an amino acid and a non-ionic detergent |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP05110701A Division EP1629832A1 (en) | 1996-04-24 | 1997-04-24 | A pharmaceutical formulation comprising human growth hormone, an amino acid and a non-ionic detergent |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP0904099A1 EP0904099A1 (en) | 1999-03-31 |
| EP0904099B1 true EP0904099B1 (en) | 2005-11-16 |
Family
ID=8094154
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP97918073A Expired - Lifetime EP0904099B1 (en) | 1996-04-24 | 1997-04-24 | Pharmaceutical formulation containing human growth hormone, histidine and a non-ionic detergent |
| EP05110701A Withdrawn EP1629832A1 (en) | 1996-04-24 | 1997-04-24 | A pharmaceutical formulation comprising human growth hormone, an amino acid and a non-ionic detergent |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP05110701A Withdrawn EP1629832A1 (en) | 1996-04-24 | 1997-04-24 | A pharmaceutical formulation comprising human growth hormone, an amino acid and a non-ionic detergent |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US20020077461A1 (pt) |
| EP (2) | EP0904099B1 (pt) |
| JP (2) | JP4176834B2 (pt) |
| KR (1) | KR20000010630A (pt) |
| CN (1) | CN1130223C (pt) |
| AT (1) | ATE309819T1 (pt) |
| AU (1) | AU733592B2 (pt) |
| BR (1) | BR9708858A (pt) |
| CA (1) | CA2252535C (pt) |
| CZ (1) | CZ298292B6 (pt) |
| DE (1) | DE69734653T2 (pt) |
| DK (1) | DK0904099T3 (pt) |
| ES (1) | ES2253774T3 (pt) |
| HU (1) | HU229868B1 (pt) |
| IL (2) | IL126463A0 (pt) |
| NO (1) | NO323360B1 (pt) |
| PL (1) | PL188222B1 (pt) |
| RU (1) | RU2236250C2 (pt) |
| UA (1) | UA66758C2 (pt) |
| WO (1) | WO1997039768A1 (pt) |
Families Citing this family (36)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5981485A (en) * | 1997-07-14 | 1999-11-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
| BR9710536A (pt) | 1996-07-24 | 1999-08-17 | Warner Lambert Co | Isobutilgaba e seus derivados para o tratamento da dor |
| AU1302499A (en) * | 1997-11-12 | 1999-05-31 | Alza Corporation | Buffered drug formulations for transdermal electrotransport delivery |
| GB9803448D0 (en) * | 1998-02-18 | 1998-04-15 | Pharma Mar Sa | Pharmaceutical formulation |
| JP4711520B2 (ja) * | 2000-03-21 | 2011-06-29 | 日本ケミカルリサーチ株式会社 | 生理活性ペプチド含有粉末 |
| JP2004515467A (ja) | 2000-08-07 | 2004-05-27 | ネクター セラピューティックス | 吸入可能な、噴霧乾燥した、最少の凝集物を有する４−ヘリックスバンドルタンパク質粉末 |
| EP1603588A2 (en) * | 2003-03-18 | 2005-12-14 | Ares Trading S.A. | Stabilisation of growth hormones in solution |
| CN102813967A (zh) | 2003-03-24 | 2012-12-12 | 普拉罗美德公司 | 利用逆向热敏聚合物的暂时栓塞 |
| DE10333317A1 (de) | 2003-07-22 | 2005-02-17 | Biotecon Therapeutics Gmbh | Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA) |
| US7700086B2 (en) * | 2003-11-06 | 2010-04-20 | Pluromed, Inc. | Internal clamp for surgical procedures |
| ES2383691T3 (es) * | 2003-12-23 | 2012-06-25 | Pharmacia Corporation | Formulación líquida estable de hormonas de crecimiento |
| UA89781C2 (uk) * | 2004-04-07 | 2010-03-10 | Арес Трейдінг С.А. | Рідкий склад гормона росту |
| MX2007007580A (es) * | 2004-12-22 | 2007-12-11 | Ambrx Inc | Hormona del crecimiento humana modificada. |
| WO2006071840A2 (en) * | 2004-12-22 | 2006-07-06 | Ambrx, Inc. | Formulations of human growth hormone comprising a non-naturally encoded amino acid |
| CN101374536B (zh) * | 2004-12-22 | 2013-09-25 | Ambrx公司 | 包含非天然编码的氨基酸的人生长激素配方 |
| AU2006286486A1 (en) | 2005-08-30 | 2007-03-08 | Novo Nordisk Health Care Ag | Liquid formulations of pegylated growth hormone |
| WO2007033427A1 (en) * | 2005-09-23 | 2007-03-29 | Metabolic Pharmaceuticals Limited | Stabilisation of peptides with basic amino acids |
| CN1939534B (zh) | 2005-09-27 | 2010-12-01 | 长春金赛药业股份有限公司 | 含有人生长激素或人粒细胞巨噬细胞刺激因子的用于治疗损伤和溃疡的外用制剂 |
| EP2049148B1 (en) * | 2006-07-06 | 2016-09-28 | Daewoong Co., Ltd. | A stable liquid formulation of human growth hormone |
| CN101495155A (zh) | 2006-07-07 | 2009-07-29 | 诺沃-诺迪斯克保健股份有限公司 | 新的蛋白结合物及其制备方法 |
| AU2007333959A1 (en) * | 2006-12-18 | 2008-06-26 | Altus Pharmaceuticals Inc. | Human growth hormone formulations |
| MX338357B (es) | 2010-01-22 | 2016-04-13 | Novo Nordisk Healthcare Ag | Compuestos estables de la hormona de crecimiento. |
| CN103002918B (zh) | 2010-01-22 | 2016-05-04 | 诺沃—诺迪斯克保健股份有限公司 | 体内功效延长的生长激素 |
| KR101337797B1 (ko) * | 2010-07-14 | 2013-12-06 | 한미사이언스 주식회사 | 지속형 인간 성장 호르몬 결합체 액상 제제 |
| ES2566781T3 (es) * | 2010-09-21 | 2016-04-15 | Ferring B.V. | Procedimiento mejorado para la producción de hormona del crecimiento humana recombinante |
| US9216219B2 (en) | 2012-06-12 | 2015-12-22 | Novartis Ag | Anti-BAFFR antibody formulation |
| MX367055B (es) | 2012-06-26 | 2019-08-02 | Del Mar Pharmaceuticals | El uso de una composición que comprende dianhidrogalactitol, diacetildianhidrogalactitol, y dibromodulcitol, y análogos o derivados de cada uno para el tratamiento de malignidades resistentes a inhibidores de tirosina cinasa. |
| WO2014166836A1 (en) | 2013-04-05 | 2014-10-16 | Novo Nordisk A/S | Growth hormone compound formulation |
| JP2016519684A (ja) | 2013-04-08 | 2016-07-07 | デニス エム ブラウン | 準最適に投与された薬物療法の有効性を改善するための及び／又は副作用を低減するための方法および組成物 |
| WO2015013579A1 (en) | 2013-07-26 | 2015-01-29 | Update Pharma Inc. | Compositions to improve the therapeutic benefit of bisantrene |
| CA2925416A1 (en) | 2013-09-27 | 2015-04-02 | Hanmi Pharm. Co., Ltd. | Sustained type human growth hormone preparation |
| US9119832B2 (en) | 2014-02-05 | 2015-09-01 | The Regents Of The University Of California | Methods of treating mild brain injury |
| WO2017075535A1 (en) | 2015-10-28 | 2017-05-04 | Oxeia Biopharmaceuticals, Inc. | Methods of treating neurodegenerative conditions |
| KR102655498B1 (ko) | 2017-09-07 | 2024-04-11 | 제이씨알 파마 가부시키가이샤 | 수성 의약 조성물 |
| TWI832871B (zh) | 2018-06-29 | 2024-02-21 | 美商英塞特公司 | Axl/mer 抑制劑之調配物 |
| CN115634284A (zh) * | 2022-10-31 | 2023-01-24 | 景泽生物医药(合肥)有限公司 | 一种促性腺激素冻干制剂及其制备方法 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5096885A (en) * | 1988-04-15 | 1992-03-17 | Genentech, Inc. | Human growth hormone formulation |
| ES2291264T3 (es) * | 1991-12-20 | 2008-03-01 | Novo Nordisk A/S | Formulacion farmaceutica estabilizada comprendiendo una hormona de crecimiento e histidina. |
| DK204791D0 (da) * | 1991-12-20 | 1991-12-20 | Novo Nordisk As | Hidtil ukendt farmaceutisk praeparat |
| CA2489978A1 (en) * | 1992-07-31 | 1994-02-17 | Genentech, Inc. | Human growth hormone aqueous formulation |
-
1997
- 1997-04-23 US US08/842,293 patent/US20020077461A1/en not_active Abandoned
- 1997-04-24 ES ES97918073T patent/ES2253774T3/es not_active Expired - Lifetime
- 1997-04-24 EP EP97918073A patent/EP0904099B1/en not_active Expired - Lifetime
- 1997-04-24 IL IL12646397A patent/IL126463A0/xx active IP Right Grant
- 1997-04-24 CZ CZ0320798A patent/CZ298292B6/cs not_active IP Right Cessation
- 1997-04-24 DE DE69734653T patent/DE69734653T2/de not_active Expired - Lifetime
- 1997-04-24 HU HU9902476A patent/HU229868B1/hu unknown
- 1997-04-24 DK DK97918073T patent/DK0904099T3/da active
- 1997-04-24 AU AU26343/97A patent/AU733592B2/en not_active Expired
- 1997-04-24 WO PCT/DK1997/000184 patent/WO1997039768A1/en active IP Right Grant
- 1997-04-24 RU RU98121135/15A patent/RU2236250C2/ru active
- 1997-04-24 UA UA98105593A patent/UA66758C2/xx unknown
- 1997-04-24 CN CN97194040A patent/CN1130223C/zh not_active Expired - Lifetime
- 1997-04-24 PL PL97329386A patent/PL188222B1/pl unknown
- 1997-04-24 JP JP53762297A patent/JP4176834B2/ja not_active Expired - Lifetime
- 1997-04-24 CA CA002252535A patent/CA2252535C/en not_active Expired - Lifetime
- 1997-04-24 EP EP05110701A patent/EP1629832A1/en not_active Withdrawn
- 1997-04-24 BR BR9708858A patent/BR9708858A/pt not_active Application Discontinuation
- 1997-04-24 KR KR1019980708535A patent/KR20000010630A/ko active Search and Examination
- 1997-04-24 AT AT97918073T patent/ATE309819T1/de active
-
1998
- 1998-10-04 IL IL126463A patent/IL126463A/en not_active IP Right Cessation
- 1998-10-23 NO NO19984951A patent/NO323360B1/no not_active IP Right Cessation
-
2008
- 2008-06-03 JP JP2008145780A patent/JP2008231124A/ja not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| EP0904099A1 (en) | 1999-03-31 |
| BR9708858A (pt) | 1999-08-03 |
| CA2252535A1 (en) | 1997-10-30 |
| DE69734653T2 (de) | 2006-08-10 |
| CN1130223C (zh) | 2003-12-10 |
| CZ320798A3 (cs) | 1999-03-17 |
| NO984951D0 (no) | 1998-10-23 |
| JP2000508665A (ja) | 2000-07-11 |
| RU2236250C2 (ru) | 2004-09-20 |
| ATE309819T1 (de) | 2005-12-15 |
| JP2008231124A (ja) | 2008-10-02 |
| IL126463A0 (en) | 1999-08-17 |
| NO984951L (no) | 1998-10-23 |
| JP4176834B2 (ja) | 2008-11-05 |
| AU2634397A (en) | 1997-11-12 |
| IL126463A (en) | 2007-06-17 |
| KR20000010630A (ko) | 2000-02-25 |
| CA2252535C (en) | 2009-06-23 |
| CN1216472A (zh) | 1999-05-12 |
| NO323360B1 (no) | 2007-04-10 |
| DK0904099T3 (da) | 2006-03-06 |
| DE69734653D1 (de) | 2005-12-22 |
| ES2253774T3 (es) | 2006-06-01 |
| HUP9902476A3 (en) | 2000-12-28 |
| PL188222B1 (pl) | 2004-12-31 |
| HUP9902476A2 (hu) | 2000-11-28 |
| HU229868B1 (en) | 2014-10-28 |
| PL329386A1 (en) | 1999-03-29 |
| WO1997039768A1 (en) | 1997-10-30 |
| US20020077461A1 (en) | 2002-06-20 |
| AU733592B2 (en) | 2001-05-17 |
| EP1629832A1 (en) | 2006-03-01 |
| CZ298292B6 (cs) | 2007-08-15 |
| UA66758C2 (en) | 2004-06-15 |
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